Masayoshi Harigai1, Tsutomu Takeuchi2, Josef S Smolen3, Kevin L Winthrop4, Atsushi Nishikawa5, Terence P Rooney6, Chadi G Saifan6, Maher Issa6, Yoshitaka Isaka5, Naotsugu Akashi5, Taeko Ishii5, Yoshiya Tanaka7. 1. Division of Epidemiology and Pharmacoepidemiology of Rheumatic Diseases, Department of Rheumatology, School of Medicine, Tokyo Women's Medical University, Tokyo, Japan. 2. Division of Rheumatology, Department of Internal Medicine, Keio University School of Medicine, Tokyo, Japan. 3. Division of Rheumatology, Department of Medicine, Medical University of Vienna, Vienna, Austria. 4. Department of Medicine & Ophthalmology, Oregon Health & Science University, Portland, OR, USA. 5. Medicines Development Unit, Eli Lilly Japan K.K., Kobe, Japan. 6. Lilly Research Laboratories, Eli Lilly and Company, Indianapolis, IN, USA. 7. First Department of Internal Medicine, School of Medicine, University of Occupational and Environmental Health, Kitakyushu, Japan.
Abstract
Objectives:Baricitinib is a selective oral inhibitor of JAK1/JAK2 for patients with moderately-to-severely active rheumatoid arthritis (RA). Baricitinib's safety profile in Japanese patients was evaluated using six studies (five Ph2/Ph3 trials, one long-term extension study through 01 September 2016) from an integrated database (nine RA studies). Methods:Incidence rates (IRs) or exposure-adjusted IRs (EAIRs) of adverse events (AEs) per 100 patient-years (PY) were calculated using data which included RA patients exposed to any baricitinib dose. Results: Five hundred and fourteen Japanese patients received baricitinib for 851.5 total PY of exposure (median 1.7 years, maximum 3.2). The EAIR of treatment-emergent AEs was 57.4/100PY. There were no deaths; 31 patients had serious infections (IR: 3.6/100PY), 55 herpes zoster (6.5), 0 tuberculosis, 10 malignancies (1.1) including two lymphomas, two major cardiovascular AEs (0.3), one gastrointestinal perforation (0.1), and four deep vein thrombosis (0.5). In Japanese patients, herpes zoster was more frequent than that of patients overall in the integrated database, but the events were considered manageable. Conclusion: In this analysis, baricitinib had acceptable safety profile in Japanese RA patients in the context of demonstrated efficacy. Aside from herpes zoster, baricitinib safety was not notably different between Japanese RA patients and those RA patients in the integrated database.Trial registration: NCT01185353, NCT00902486, NCT01469013, NCT01710358, NCT01721044, NCT01721057, NCT01711359, and NCT01885078 at https://clinicaltrials.gov/.
RCT Entities:
Objectives:Baricitinib is a selective oral inhibitor of JAK1/JAK2 for patients with moderately-to-severely active rheumatoid arthritis (RA). Baricitinib's safety profile in Japanese patients was evaluated using six studies (five Ph2/Ph3 trials, one long-term extension study through 01 September 2016) from an integrated database (nine RA studies). Methods: Incidence rates (IRs) or exposure-adjusted IRs (EAIRs) of adverse events (AEs) per 100 patient-years (PY) were calculated using data which included RApatients exposed to any baricitinib dose. Results: Five hundred and fourteen Japanese patients received baricitinib for 851.5 total PY of exposure (median 1.7 years, maximum 3.2). The EAIR of treatment-emergent AEs was 57.4/100PY. There were no deaths; 31 patients had serious infections (IR: 3.6/100PY), 55 herpes zoster (6.5), 0 tuberculosis, 10 malignancies (1.1) including two lymphomas, two major cardiovascular AEs (0.3), one gastrointestinal perforation (0.1), and four deep vein thrombosis (0.5). In Japanese patients, herpes zoster was more frequent than that of patients overall in the integrated database, but the events were considered manageable. Conclusion: In this analysis, baricitinib had acceptable safety profile in Japanese RApatients in the context of demonstrated efficacy. Aside from herpes zoster, baricitinib safety was not notably different between Japanese RApatients and those RApatients in the integrated database.Trial registration: NCT01185353, NCT00902486, NCT01469013, NCT01710358, NCT01721044, NCT01721057, NCT01711359, and NCT01885078 at https://clinicaltrials.gov/.
Authors: Fabiola Atzeni; Javier Rodríguez-Carrio; Călin D Popa; Michael T Nurmohamed; Gabriella Szűcs; Zoltán Szekanecz Journal: Nat Rev Rheumatol Date: 2021-04-08 Impact factor: 20.543
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Authors: Karel Pavelka; Zoltán Szekanecz; Nemanja Damjanov; Branimir Anić; Matija Tomšič; Vadim Mazurov; Marija Maksimovic; Orsolya Nagy; Jerzy Świerkot; Tzvetanka Petranova; Tiina Veldi; Asta Baranauskaitė; Catalin Codreanu; Daina Andersone; Roy Fleischmann Journal: Drugs Context Date: 2020-10-19